A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Corcept Therapeutics
Study ID
NCT03697109
Phase
PHASE3
Status
Completed

Conditions

  • Cushing Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Relacorilant — DRUG
    Relacorilant is supplied as 100 mg capsules for oral dosing.
  • Placebo — OTHER
    Placebo matched to study drug

Study Details

This is a Phase 3, double-blind, placebo-controlled, randomized-withdrawal study to assess the efficacy, safety and pharmacokinetics (PK) of relacorilant in patients with endogenous Cushing syndrome and concurrent type 2 diabetes mellitus/impaired glucose tolerance (DM/IGT) and/or uncontrolled hypertension (HTN).

Key Dates

First listed
Oct 5, 2018
Start date
Nov 15, 2018
Status verified
Apr 2025
Primary completion
Apr 8, 2024
Completion
Apr 15, 2024

Study Design

Enrollment
152 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Relacorilant (OL Phase)
    Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
  • Experimental: Relacorilant (RW Phase)
    Patients who meet any of the response criteria will advance to the RW Phase of the study and receive the same dose of relacorilant as the last dose administered in the OL Phase.
  • Placebo Comparator: Placebo (RW Phase)
    Patients who meet any of the response criteria will advance to the RW Phase of the study and receive placebo matched to study drug.

Primary Outcome Measure

Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase. [ Time Frame: Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) ]

Locations (32)

FacilityCityStateZIPSite coordinators
Site 21PhoenixArizona85013-
Site 36Los AngelesCalifornia90095-
Site 68TorranceCalifornia90502-
Site 10MiamiFlorida33136-
Site 14AtlantaGeorgia30318-
Site 41ChicagoIllinois60611-
Site 7IndianapolisIndiana46202-
Site 2MetairieLouisiana70006-
Site 45BaltimoreMaryland21205-
Site 46BostonMassachusetts02115-
Site 20Ann ArborMichigan48109-
Site 4JacksonMississippi39202-
Site 13St LouisMissouri63110-
Site 53OmahaNebraska68198-
Site 72RenoNevada89511-
Site 8AlbanyNew York12203-
Site 6JamaicaNew York11432-
Site 35New YorkNew York10029-
Site 39New YorkNew York10065-
Site 57New YorkNew York10021-
Site 1WilmingtonNorth Carolina28401-
Site 17ColumbusOhio43210-
Site 11Oklahoma CityOklahoma73104-
Site 62PhiladelphiaPennsylvania19107-
Site 19PittsburghPennsylvania15212-
Site 71PittsburghPennsylvania15213-
Site 5SummervilleSouth Carolina29485-
Site 51DallasTexas75390-
Site 3El PasoTexas79935-
Site 65HoustonTexas77079-
Site 56Shavano ParkTexas78231-
Site 31EverettWashington98201-

Find similar trials in Phoenix, AZ

By research site
Site 21· Phoenix, AZSite 36· Los Angeles, CASite 68· Torrance, CASite 10· Miami, FLSite 14· Atlanta, GASite 41· Chicago, IL

Related Studies